Hypercholesterolemia
Conditions
Keywords
HMG-CoA, LDL-C, CHD
Brief summary
This trial is to compare the efficacy, safety and tolerability of Rosuvastatin with Atorvastatin by assessing the change of LDL-C in patients with hypercholesterolemia and history of coronary heart disease (CHD) or risk equivalent, or a 10 year CHD risk of no less than 10%, following 6-week treatment and a possible 6 week extension treatment.
Interventions
DRUGRosuvastatin
Capsule/Tablet, oral, qd, 6 or 12 weeks
DRUGAtorvastatin
Capsule/Tablet, 10mg, oral, qd, 6 weeks
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Treated for or diagnosed hypercholesterolemia or have had a high risk with hypercholesterolemia * LDL-C between 3.36mmol/L and 6.5 mmol/L if not treated with statin or between 2.6mmol/L and 4.14 mmol/L * Fasting triglyceride less than 4.52mmol/L
Exclusion criteria
* History of statin induced myopathy * Unstable or uncontrolled cardiovascular diseases * Familial dysbetalipoproteinemia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) Concentration After 6 Weeks of Treatment Comparing Rosuvastatin 5mg With Atorvastatin 10mg | baseline, 6 weeks | Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a two-sided significance level of 0.025 on ITT population. |
| Percentage Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) Concentration After 6 Weeks of Treatment Comparing Rosuvastatin 10mg With Atorvastatin 10mg | baseline, 6 weeks | Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.025 on ITT population. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Change From Baseline in Triglycerides (TG) at Week 6 | baseline, 6 weeks | Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population. |
| Percentage Change From Baseline in Non High Density Lipoprotein-Cholesterol (nonHDL-C) at Week 6 | baseline, 6 weeks | Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population. |
| Percentage Change From Baseline in Apolipoprotein B (ApoB) at Week 6 | baseline, 6 weeks | Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population. |
| Percentage Change From Baseline in Apolipoprotein A-I (ApoA-I) at Week 6 | baseline, 6 weeks | Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population. |
| Percentage Change From Baseline in Total Cholesterol/High Density Lipoprotein-Cholesterol (TC/HDL-C) at Week 6 | baseline, 6 weeks | Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population. |
| Percentage Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 6 | baseline, 6 weeks | Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population. |
| Percentage Change From Baseline in Non High Density Lipoprotein Cholesterol/High Density Lipoprotein Cholesterol (nonHDL-C/HDL-C) at Week 6 | baseline, 6 weeks | Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population. |
| Percentage Change From Baseline in Apolipoprotein B/Apolipoprotein A I (ApoB/ApoA-I) at Week 6 | baseline, 6 weeks | Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population. |
| Percentage of Patients Achieved ATP III Guideline (2001) Low Density Lipoprotein Cholesterol (LDL-C) Goal at Week 6 | week 6 | The percentage of patients achieved LDL-C goal is done in ITT population. National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) guideline (2001) LDL-C goal: Moderately high risk: 2+ risk factors (10-year risk 10%-20%): LDL-C goal \< 3.36mmol/L(130mg/dL), non-HDL-C goal \< 4.14mmol/L (160mg/dL) ; High risk: Coronary Heart Disease (CHD) or CHD risk equivalents (10-year risk \>20%): LDL-C goal\< 2.60mmol/L (100mg/dL), non-HDL-C goal \< 3.36mmol/L (130mg/dL) |
| 6 weeksPercentage of Patients Achieved ATP III Guideline (2001) Non High Density Lipoprotein-Cholesterol (nonHDL-C) Goal at Week 6 | week 6 | The percentage of patients achieved LDL-C goal is done in ITT population. National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) guideline (2001) LDL-C goal: Moderately high risk: 2+ risk factors (10-year risk 10%-20%): LDL-C goal \< 3.36mmol/L(130mg/dL); non-HDL-C goal \< 4.14mmol/L (160mg/dL) ; High risk: Coronary Heart Disease (CHD) or CHD risk equivalents (10-year risk \>20%): LDL-C goal\< 2.60mmol/L (100mg/dL),non-HDL-C goal \< 3.36mmol/L (130mg/dL) |
| Percentage of Patients Achieved National Cholesterol Education Program Adult Treatment Panel (NCEP ATP) III Guideline (2001) Low Density Lipoprotein-Cholesterol (LDL-C) Goal After Titration | from week 6 to week 12 | The percentage of patients achieved LDL-C goal is done in ITT population. National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) guideline (2001) LDL-C goal: Moderately high risk: 2+ risk factors (10-year risk 10%-20%): LDL-C goal \< 3.36mmol/L(130mg/dL), non-HDL-C goal \< 4.14mmol/L (160mg/dL) ; High risk: Coronary Heart Disease (CHD) or CHD risk equivalents (10-year risk \>20%): LDL-C goal\< 2.60mmol/L (100mg/dL), non-HDL-C goal \< 3.36mmol/L (130mg/dL) |
| Percentage Change From Baseline in Low Density Lipoprotein Cholesterol/High Density Lipoprotein Cholesterol (LDL-C/HDL-C) at Week 6 | baseline, 6 weeks | Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population. |
| Percentage Change From Baseline in Total Cholesterol (TC ) at Week 6 | baseline, 6 weeks | Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population. |
Countries
China
Participant flow
Recruitment details
In total 934 patients were enrolled to the study, the study was conducted at 13 investigational sites in China. The first patient was enrolled on 27 May 2008, the last patient was completed on 16 Jul 2009.
Pre-assignment details
There is a dietary lead in period before randomization. 934 patients started the dietary lead in period. 436 patients completed this period. The baseline measurement is based on the ITT population. Patients included in ITT population in each arm is : Rosuvastatin 5mg 136, Rosuvastatin 10mg 139 and Atorvastatin 10mg 139.
Participants by arm
| Arm | Count |
|---|---|
| Rosuvastatin 5mg Taken orally once daily | 136 |
| Rosuvastatin 10mg Taken orally once daily | 139 |
| Atorvastatin 10mg Taken orally once daily | 139 |
| Total | 414 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Extension Treatment Period | Adverse Event | 1 | 0 | 0 |
| Extension Treatment Period | Protocol Violation | 1 | 0 | 0 |
| Extension Treatment Period | Withdrawal by Subject | 1 | 0 | 0 |
| Randomised Treatment Period | Adverse Event | 2 | 0 | 2 |
| Randomised Treatment Period | Protocol Violation | 0 | 1 | 0 |
| Randomised Treatment Period | Reason not provided | 0 | 0 | 2 |
| Randomised Treatment Period | Withdrawal by Subject | 4 | 1 | 2 |
Baseline characteristics
| Characteristic | Rosuvastatin 5mg | Rosuvastatin 10mg | Atorvastatin 10mg | Total |
|---|---|---|---|---|
| Age Continuous | 60.4 Years STANDARD_DEVIATION 8.51 | 59.7 Years STANDARD_DEVIATION 10.57 | 58.4 Years STANDARD_DEVIATION 9.29 | 59.5 Years STANDARD_DEVIATION 9.51 |
| Low density lipoprotein cholesterol (LDL-C level) | 4.242 mmol/L STANDARD_DEVIATION 0.6769 | 4.131 mmol/L STANDARD_DEVIATION 0.6818 | 4.213 mmol/L STANDARD_DEVIATION 0.6617 | 4.186 mmol/L STANDARD_DEVIATION 0.6717 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 136 Participants | 139 Participants | 139 Participants | 414 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Nativ Hawaiian or other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 84 Participants | 85 Participants | 77 Participants | 246 Participants |
| Sex: Female, Male Male | 52 Participants | 54 Participants | 62 Participants | 168 Participants |
| triglyceride (TG) level | 1.921 mmol/L STANDARD_DEVIATION 0.7825 | 2.042 mmol/L STANDARD_DEVIATION 0.9164 | 2.061 mmol/L STANDARD_DEVIATION 0.8971 | 1.991 mmol/L STANDARD_DEVIATION 0.8494 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 5 / 145 | 3 / 145 | 0 / 146 |
| serious Total, serious adverse events | 1 / 145 | 0 / 145 | 1 / 146 |
Outcome results
Primary
Percentage Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) Concentration After 6 Weeks of Treatment Comparing Rosuvastatin 10mg With Atorvastatin 10mg
Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.025 on ITT population.
Time frame: baseline, 6 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Rosuvastatin 5mg | Percentage Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) Concentration After 6 Weeks of Treatment Comparing Rosuvastatin 10mg With Atorvastatin 10mg | -46.28 Percent change | Standard Error 2.62 |
| Atorvastatin 10mg | Percentage Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) Concentration After 6 Weeks of Treatment Comparing Rosuvastatin 10mg With Atorvastatin 10mg | -38.67 Percent change | Standard Error 2.64 |
Primary
Percentage Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) Concentration After 6 Weeks of Treatment Comparing Rosuvastatin 5mg With Atorvastatin 10mg
Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a two-sided significance level of 0.025 on ITT population.
Time frame: baseline, 6 weeks
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Rosuvastatin 5mg | Percentage Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) Concentration After 6 Weeks of Treatment Comparing Rosuvastatin 5mg With Atorvastatin 10mg | -41.70 percent change | Standard Error 2.62 |
| Atorvastatin 10mg | Percentage Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) Concentration After 6 Weeks of Treatment Comparing Rosuvastatin 5mg With Atorvastatin 10mg | -38.67 percent change | Standard Error 2.64 |
Secondary
6 weeksPercentage of Patients Achieved ATP III Guideline (2001) Non High Density Lipoprotein-Cholesterol (nonHDL-C) Goal at Week 6
The percentage of patients achieved LDL-C goal is done in ITT population. National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) guideline (2001) LDL-C goal: Moderately high risk: 2+ risk factors (10-year risk 10%-20%): LDL-C goal \< 3.36mmol/L(130mg/dL); non-HDL-C goal \< 4.14mmol/L (160mg/dL) ; High risk: Coronary Heart Disease (CHD) or CHD risk equivalents (10-year risk \>20%): LDL-C goal\< 2.60mmol/L (100mg/dL),non-HDL-C goal \< 3.36mmol/L (130mg/dL)
Time frame: week 6
Population: Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rosuvastatin 5mg | 6 weeksPercentage of Patients Achieved ATP III Guideline (2001) Non High Density Lipoprotein-Cholesterol (nonHDL-C) Goal at Week 6 | 66.9 percentage of patients |
| Atorvastatin 10mg | 6 weeksPercentage of Patients Achieved ATP III Guideline (2001) Non High Density Lipoprotein-Cholesterol (nonHDL-C) Goal at Week 6 | 78.4 percentage of patients |
| Atorvastatin 10mg | 6 weeksPercentage of Patients Achieved ATP III Guideline (2001) Non High Density Lipoprotein-Cholesterol (nonHDL-C) Goal at Week 6 | 60.4 percentage of patients |
Secondary
Percentage Change From Baseline in Apolipoprotein A-I (ApoA-I) at Week 6
Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.
Time frame: baseline, 6 weeks
Population: Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Rosuvastatin 5mg | Percentage Change From Baseline in Apolipoprotein A-I (ApoA-I) at Week 6 | 3.67 percent change | Standard Error 1.99 |
| Atorvastatin 10mg | Percentage Change From Baseline in Apolipoprotein A-I (ApoA-I) at Week 6 | 4.25 percent change | Standard Error 1.98 |
| Atorvastatin 10mg | Percentage Change From Baseline in Apolipoprotein A-I (ApoA-I) at Week 6 | 1.79 percent change | Standard Error 2 |
Secondary
Percentage Change From Baseline in Apolipoprotein B (ApoB) at Week 6
Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.
Time frame: baseline, 6 weeks
Population: Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Rosuvastatin 5mg | Percentage Change From Baseline in Apolipoprotein B (ApoB) at Week 6 | -36.55 percent change | Standard Error 2.4 |
| Atorvastatin 10mg | Percentage Change From Baseline in Apolipoprotein B (ApoB) at Week 6 | -41.21 percent change | Standard Error 2.4 |
| Atorvastatin 10mg | Percentage Change From Baseline in Apolipoprotein B (ApoB) at Week 6 | -34.67 percent change | Standard Error 2.41 |
Secondary
Percentage Change From Baseline in Apolipoprotein B/Apolipoprotein A I (ApoB/ApoA-I) at Week 6
Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.
Time frame: baseline, 6 weeks
Population: Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Rosuvastatin 5mg | Percentage Change From Baseline in Apolipoprotein B/Apolipoprotein A I (ApoB/ApoA-I) at Week 6 | -37.62 percent change | Standard Error 3.15 |
| Atorvastatin 10mg | Percentage Change From Baseline in Apolipoprotein B/Apolipoprotein A I (ApoB/ApoA-I) at Week 6 | -41.87 percent change | Standard Error 3.14 |
| Atorvastatin 10mg | Percentage Change From Baseline in Apolipoprotein B/Apolipoprotein A I (ApoB/ApoA-I) at Week 6 | -35.15 percent change | Standard Error 3.16 |
Secondary
Percentage Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 6
Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.
Time frame: baseline, 6 weeks
Population: Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Rosuvastatin 5mg | Percentage Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 6 | 5.63 percent change | Standard Error 2.29 |
| Atorvastatin 10mg | Percentage Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 6 | 6.82 percent change | Standard Error 2.29 |
| Atorvastatin 10mg | Percentage Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) at Week 6 | 3.64 percent change | Standard Error 2.31 |
Secondary
Percentage Change From Baseline in Low Density Lipoprotein Cholesterol/High Density Lipoprotein Cholesterol (LDL-C/HDL-C) at Week 6
Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.
Time frame: baseline, 6 weeks
Population: Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Rosuvastatin 5mg | Percentage Change From Baseline in Low Density Lipoprotein Cholesterol/High Density Lipoprotein Cholesterol (LDL-C/HDL-C) at Week 6 | -44.07 percent change | Standard Error 3.17 |
| Atorvastatin 10mg | Percentage Change From Baseline in Low Density Lipoprotein Cholesterol/High Density Lipoprotein Cholesterol (LDL-C/HDL-C) at Week 6 | -50.27 percent change | Standard Error 3.16 |
| Atorvastatin 10mg | Percentage Change From Baseline in Low Density Lipoprotein Cholesterol/High Density Lipoprotein Cholesterol (LDL-C/HDL-C) at Week 6 | -41.04 percent change | Standard Error 3.19 |
Secondary
Percentage Change From Baseline in Non High Density Lipoprotein Cholesterol/High Density Lipoprotein Cholesterol (nonHDL-C/HDL-C) at Week 6
Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.
Time frame: baseline, 6 weeks
Population: Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Rosuvastatin 5mg | Percentage Change From Baseline in Non High Density Lipoprotein Cholesterol/High Density Lipoprotein Cholesterol (nonHDL-C/HDL-C) at Week 6 | -41.79 percent change | Standard Error 11.54 |
| Atorvastatin 10mg | Percentage Change From Baseline in Non High Density Lipoprotein Cholesterol/High Density Lipoprotein Cholesterol (nonHDL-C/HDL-C) at Week 6 | -56.63 percent change | Standard Error 11.52 |
| Atorvastatin 10mg | Percentage Change From Baseline in Non High Density Lipoprotein Cholesterol/High Density Lipoprotein Cholesterol (nonHDL-C/HDL-C) at Week 6 | -48.33 percent change | Standard Error 11.64 |
Secondary
Percentage Change From Baseline in Non High Density Lipoprotein-Cholesterol (nonHDL-C) at Week 6
Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.
Time frame: baseline, 6 weeks
Population: Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Rosuvastatin 5mg | Percentage Change From Baseline in Non High Density Lipoprotein-Cholesterol (nonHDL-C) at Week 6 | -38.60 percent change | Standard Error 3.57 |
| Atorvastatin 10mg | Percentage Change From Baseline in Non High Density Lipoprotein-Cholesterol (nonHDL-C) at Week 6 | -46.08 percent change | Standard Error 3.57 |
| Atorvastatin 10mg | Percentage Change From Baseline in Non High Density Lipoprotein-Cholesterol (nonHDL-C) at Week 6 | -38.50 percent change | Standard Error 3.6 |
Secondary
Percentage Change From Baseline in Total Cholesterol/High Density Lipoprotein-Cholesterol (TC/HDL-C) at Week 6
Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.
Time frame: baseline, 6 weeks
Population: Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Rosuvastatin 5mg | Percentage Change From Baseline in Total Cholesterol/High Density Lipoprotein-Cholesterol (TC/HDL-C) at Week 6 | -32.95 percent change | Standard Error 2.96 |
| Atorvastatin 10mg | Percentage Change From Baseline in Total Cholesterol/High Density Lipoprotein-Cholesterol (TC/HDL-C) at Week 6 | -38.04 percent change | Standard Error 2.96 |
| Atorvastatin 10mg | Percentage Change From Baseline in Total Cholesterol/High Density Lipoprotein-Cholesterol (TC/HDL-C) at Week 6 | -31.92 percent change | Standard Error 2.99 |
Secondary
Percentage Change From Baseline in Total Cholesterol (TC ) at Week 6
Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.
Time frame: baseline, 6 weeks
Population: Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Rosuvastatin 5mg | Percentage Change From Baseline in Total Cholesterol (TC ) at Week 6 | -29.62 percent change | Standard Error 1.92 |
| Atorvastatin 10mg | Percentage Change From Baseline in Total Cholesterol (TC ) at Week 6 | -33.14 percent change | Standard Error 1.91 |
| Atorvastatin 10mg | Percentage Change From Baseline in Total Cholesterol (TC ) at Week 6 | -28.06 percent change | Standard Error 1.93 |
Secondary
Percentage Change From Baseline in Triglycerides (TG) at Week 6
Analyzed with analysis of covariance (ANCOVA) model with factors fitted for treatment, centre, risk factor, lipid concentration at baseline, treatment by centre and treatment by risk factor with a significance level of 0.05 on ITT population.
Time frame: baseline, 6 weeks
Population: Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Rosuvastatin 5mg | Percentage Change From Baseline in Triglycerides (TG) at Week 6 | -20.09 Percent change | Standard Error 4.72 |
| Atorvastatin 10mg | Percentage Change From Baseline in Triglycerides (TG) at Week 6 | -22.05 Percent change | Standard Error 4.69 |
| Atorvastatin 10mg | Percentage Change From Baseline in Triglycerides (TG) at Week 6 | -20.67 Percent change | Standard Error 4.73 |
Secondary
Percentage of Patients Achieved ATP III Guideline (2001) Low Density Lipoprotein Cholesterol (LDL-C) Goal at Week 6
The percentage of patients achieved LDL-C goal is done in ITT population. National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) guideline (2001) LDL-C goal: Moderately high risk: 2+ risk factors (10-year risk 10%-20%): LDL-C goal \< 3.36mmol/L(130mg/dL), non-HDL-C goal \< 4.14mmol/L (160mg/dL) ; High risk: Coronary Heart Disease (CHD) or CHD risk equivalents (10-year risk \>20%): LDL-C goal\< 2.60mmol/L (100mg/dL), non-HDL-C goal \< 3.36mmol/L (130mg/dL)
Time frame: week 6
Population: Patients who have baseline HDL-C and at least one post baseline HDL-C. Not all patients in ITT meet the conditions since ITT is for all lipid variables instead of individual variable.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rosuvastatin 5mg | Percentage of Patients Achieved ATP III Guideline (2001) Low Density Lipoprotein Cholesterol (LDL-C) Goal at Week 6 | 61.0 percentage of patients |
| Atorvastatin 10mg | Percentage of Patients Achieved ATP III Guideline (2001) Low Density Lipoprotein Cholesterol (LDL-C) Goal at Week 6 | 79.1 percentage of patients |
| Atorvastatin 10mg | Percentage of Patients Achieved ATP III Guideline (2001) Low Density Lipoprotein Cholesterol (LDL-C) Goal at Week 6 | 58.3 percentage of patients |
Secondary
Percentage of Patients Achieved National Cholesterol Education Program Adult Treatment Panel (NCEP ATP) III Guideline (2001) Low Density Lipoprotein-Cholesterol (LDL-C) Goal After Titration
The percentage of patients achieved LDL-C goal is done in ITT population. National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) guideline (2001) LDL-C goal: Moderately high risk: 2+ risk factors (10-year risk 10%-20%): LDL-C goal \< 3.36mmol/L(130mg/dL), non-HDL-C goal \< 4.14mmol/L (160mg/dL) ; High risk: Coronary Heart Disease (CHD) or CHD risk equivalents (10-year risk \>20%): LDL-C goal\< 2.60mmol/L (100mg/dL), non-HDL-C goal \< 3.36mmol/L (130mg/dL)
Time frame: from week 6 to week 12
Population: Patients did not achieve NCEP ATP III LDL-C goal at the end of 6 weeks randomised treatment period, they entered into extension treatment period upon investigator's discretion.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rosuvastatin 5mg | Percentage of Patients Achieved National Cholesterol Education Program Adult Treatment Panel (NCEP ATP) III Guideline (2001) Low Density Lipoprotein-Cholesterol (LDL-C) Goal After Titration | 41.2 percentage of patients |
| Atorvastatin 10mg | Percentage of Patients Achieved National Cholesterol Education Program Adult Treatment Panel (NCEP ATP) III Guideline (2001) Low Density Lipoprotein-Cholesterol (LDL-C) Goal After Titration | 47.6 percentage of patients |